DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating macular degeneration in a human in need thereof via administering the claimed extract to the human, does not reasonably provide enablement for preventing macular degeneration in the human. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;
2) the breadth of the claims;
3) the predictability or unpredictability of the art
4) the amount of direction or guidance presented;
5) the presence or absence of working examples;
6) the quantity of experimentation necessary;
7) the state of the prior art; and,
8) the relative skill of those skilled in the art.
With respect to the Wands factors above (particularly as they pertain to the quantity of experimentation necessary as well as the state of the prior art within the medical field), Applicants have reasonably demonstrated/disclosed that the claimed extract composition is useful as a therapeutic agent for treating macular degeneration. However, the claims also encompass using the claimed extract to prevent macular degeneration from occurring (which encompasses preventing all conceivable types of macular degeneration which is recognized in the art as being difficult to treat, much less prevent) which is clearly beyond the scope of the instantly disclosed/claimed invention. Please note that the term "prevent" encompasses absolutely preventing which reads upon completely stopping macular degeneration from occurring and, thus, requires a higher standard for enablement than does "treat", especially since it is notoriously well accepted in the medical art that the vast majority of afflictions/disorders suffered by mankind cannot be totally prevented with current therapies - including preventing macular degeneration (which clearly are not recognized in the medical art as being totally preventable).
According, it would take undue experimentation without a reasonable expectation for one of skill the art to prevent macular degeneration in a human via administering the claimed extract thereto – as instantly claimed.
Applicant argues that allegedly the experimental results confirmed that pretreatment with the ginseng berry extract inhibited ARPE-19 cell death.
While this is noted, it is also noted that there is no evidence to prove that the macular degeneration is absolutely prevented. In other words, there is nothing to show that the macular degeneration is completely stopped from occurring which has NOT been shown.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 13 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by KR 20130044712.
KR teaches a pharmaceutical composition and a food composition for preventing or relieving (treating) macular degeneration, containing syringaresinol isolated from ginseng fruit (same as berry) pulp extract, see claims 1-4, 7 and 8 and paragraphs 27-33. KR uses water as the solvent, see paragraph 14. Note that “ginseng” will read on Panax ginseng inherently. It is inherent to the extract of KR that the extract of KR will contain ginsenoside Re, Rc or Rd and that it will inherently also have the activities in claims 5 and 6 since it is from the same plant using the same extractant, water.
Applicant argues that allegedly the berries of ginseng have a higher ginsenoside content including ginsenoside Re than ginseng root. While this is very interesting, it is clear that the ginseng in KR is from berries thus the argument is moot since inherently the berries in KR will meet the claimed properties since they are the same as claimed. Applicant argues that inherently the claimed method is configured to inhibit AE2 accumulation in retinal pigment epithelial cells, death of retinal pigment epithelial cells induced by blue light or damage to an outer nuclear layer of visual cells. While this is interesting, since KR is also using berries of ginseng, it is inherent that the ginseng berries in KR will have the same properties as claimed.
Applicant next argues that the composition is configured to inhibit … damage to an outer nuclear layer of visual cells but once again, this is inherent to the berries of ginseng as taught in KR.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20130044712.
KR teaches a pharmaceutical composition and a food composition for preventing or relieving (treating) macular degeneration, containing syringaresinol isolated from ginseng fruit (same as berry) pulp extract, see claims 1-4, 7 and 8 and paragraphs 27-33. KR uses water as the solvent, see paragraph 14. Note that “ginseng” will read on Panax ginseng inherently. It is inherent to the extract of KR that the extract of KR will contain ginsenoside Re, Rc or Rd and that it will inherently also have the activities in claims 5 and 6 since it is from the same plant using the same extractant, water.
In the event it is seen that the extract of KR will not have the inherent characteristics as claimed or the compounds of claim 4 (which is NOT being admitted), then it would have been obvious to one having ordinary skill in the art to use the amounts of the ginseng berry extract to containing the claimed compounds and display the activities in claims 5 and 6 in an effort to optimize the desired results.
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Applicant argues that allegedly the berries of ginseng have a higher ginsenoside content including ginsenoside Re than ginseng root. While this is very interesting, it is clear that the ginseng in KR is from berries thus the argument is moot since inherently the berries in KR will meet the claimed properties since they are the same as claimed. Applicant argues that inherently the claimed method is configured to inhibit AE2 accumulation in retinal pigment epithelial cells, death of retinal pigment epithelial cells induced by blue light or damage to an outer nuclear layer of visual cells. While this is interesting, since KR is also using berries of ginseng, it is inherent that the ginseng berries in KR will have the same properties as claimed.
Applicant next argues that the composition is configured to inhibit … damage to an outer nuclear layer of visual cells but once again, this is inherent to the berries of ginseng as taught in KR.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655